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Synchron 467868

by Beckman Coulter, Inc.

Ref 467868

Synchron 467868 is an in vitro diagnostic device (EU IVDD general IVD; FDA Class I; FDA product code CEO, Phosphomolybdate (Colorimetric), Inorganic Phosphorus) made by Beckman Coulter, Inc., registered in EUDAMED on 10 Jun 2022 (Basic UDI-DI B-467868S8) and listed in FDA GUDID since 24 Aug 2016 (UDI-DI D-467868S8), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-467868S8 Basic UDI-DI D-467868S8UDI-DIDate10 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-467868S8 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-467868S8 registered 10 Jun 2022 Active
  • FDA GUDID UDI-DI D-467868S8 listed 24 Aug 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID D-467868S8
  2. Registered EUDAMED B-467868S8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
SYNCHRON Systems Phosphorus Reagent EUDAMED
Synchron GUDID
Generic name
Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Model / Ref / Catalog
467868
Primary DI / UDI-DI
D-467868S8 EUDAMED
15099590233358 GUDID
Basic UDI-DI
B-467868S8
FDA product code
CEO
EMDN code
W01010307 Phosphate inorganic / phosphorus
GMDN term
Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1580
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-467868S8
GUDID
15099590233358
Device classEUDAMED
Class IVD General
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-467868S8; FDA GUDID lists 15099590233358), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under PHOSPHATE INORGANIC / PHOSPHORUS.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single use
  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)